Dr. John Jenkins brings more than 25 years of leadership experience from the FDA, where he served as a senior executive within the Center for Drug Evaluation and Research (CDER) and was a long‑standing member of the Agency’s senior leadership team.  

Most notably, John served as Director of the Office of New Drugs (OND) from 2002 to 2017, where he oversaw regulatory review across all therapeutic areas, leading more than 1,000 staff and 19 review divisions. In this role, he was responsible for the review and approval of thousands of new drug and biologics applications, the implementation of the Prescription Drug User Fee Act (PDUFA), and the establishment of the FDA’s modern biosimilars review framework.  

At ELIQUENT, John provides senior‑level strategic regulatory insight to pharmaceutical and biotechnology companies, advising on complex development programs, regulatory strategy, and high‑stakes agency interactions. His experience spans novel drug development, biologics, biosimilars, and lifecycle management, with a particular focus on advising at critical program and portfolio inflection points.